DRP · Tourniquet, Automatic Rotating

Cardiovascular · 21 CFR 870.5925 · Class 2

Overview

Product CodeDRP
Device NameTourniquet, Automatic Rotating
Regulation21 CFR 870.5925
Device ClassClass 2
Review PanelCardiovascular
3rd-Party ReviewableYes

Identification

An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.

Classification Rationale

Class II (performance standards).

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Innolitics

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